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Pharm 225 > Bioequivalence > Flashcards

Bioequivalence Flashcards

1
Q

What is a generic product?

A

copy of brand name with same active ingredient for same therapuetic use

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2
Q

Before bioequivalency what was the main issue causing differing performance of generics?

A

impaired absorption and F

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3
Q

What was the first study to look at Cp?

A

chemicals in beaker to test blood alcohol level

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4
Q

What event caused the creation of the FDC act?

A

sulfanilamide in drugs which is toxic- now this act ensures drug safety

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5
Q

When was the ammendement to the FDC act that made sure drugs were efficacious not just safe?

A

1962

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6
Q

What happened after the ammendment to the FDC act?

A

generic companies stopped making generics

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7
Q

What act restored generic production? What does it do?

A

Drug Price competition and patent term restoration act
Made ANDA- just had to show BE

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8
Q

Why did it take so long to have BE standard?

A

hard to measure [] until 1984

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9
Q

Can generic companies be sued over failing to warn of a side effect NOT listed on the brand name?

A

NO

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10
Q

What does pharmaceutical equivalents mean?

A

exact same amount of medical ingredients - not same non medicinal components

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11
Q

What is US definition of bioavailability?

A

rate and extend of active ingredient is absorbed and reaches site of action

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12
Q

What is CND definition of biovailability?

A

rate and extent of absorption of drug

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13
Q

What is US definition of BE?

A

no significant difference b/w rate and extent become available at site of action

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14
Q

What is CND definition of BE?

A

lots of similarity of bioavailabilities of 2 products with same dose, unlikely to produce clinically relevant differences

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15
Q

What is the main difference b/w US and CND definitions of BE?

A

CND- looks at effect
US- looks at [] at site

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16
Q

What are some physiological factors that affect BA?

A

membrane permeability, pH, motility, age

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17
Q

What is absolute BA and relative?

A

Absolute= oral to IV
Relative= different forms by same route

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18
Q

What does AUC tell you?

A

extent

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19
Q

WHat tells you the rate of absorb and which is the easiest to measure?

A

ka, Tmax, Cmax
Cmax is easiest

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20
Q

What is meant by apparent rate constant?

A

Ka from the drug product so dissolition and liberation also occur

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21
Q

When can you waive BE test?

A

no issue with absorb, IV, topical, inhalation

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22
Q

What test do we do if a PK-BE is not possible?

A

PD-BE

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23
Q

What happens if you cant do a PD or PK study?

A

clinical study- usually for topicals

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24
Q

When do you look at early exposure for drugs?

A

if fast acting

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25
Q

What is a SOD study design?

A

2 products that wil crossover to test

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26
Q

Pros of crossover

A

lowers intersubject variability, can easily replicate,lowers study size

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27
Q

When do you consider doing a parallel study?

A

if drug has a very long half life or depot formulations

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28
Q

What is the minimum number of subjects?

A

12

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29
Q

How many samples should be collected per subject per dose? How many 1/2 lives should you measure?

A

12 sample
3 half lives

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30
Q

What is a significant washout time?

A

10 half lives

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31
Q

What are pros of multiple dose administration studies?

A

good for patients unethical to d/c treat
get all data points

32
Q

For multiple dose studies, what parameters characterize rate and extent of BA?

A

AUC
% fluctuation

33
Q

For BE in old days what was the criteria?

A

mean AUC within 20%

34
Q

What must be done to the data to statistically analyze them?

A

log trasnformed

35
Q

What is current BE criteria?

A

when log trasnformed 90% CI between 80-125%

36
Q

What are the 3 BE comparisons?

A

population
individual
population and individual

37
Q

What does a statistical analysis assumes?

A

Normal
independent- random variables are independent
homoscedasticity-variance of dependent is constant

38
Q

What test do you do if looking at variability in one patient or even between subjects?

A

ANOVA

39
Q

What is residual variance?

A

error of ANOVA
estimation of within subject variance
product variability

40
Q

What is a null hypothesis?

A

no difference

41
Q

DO A PRACTICE CI QUESTION

A

90%CI=100 x e^(Difference +- t(n1+n2-2) x SE difference)
difference= difference in log means of T and R
t= tvalue NOT time
n thing= degree of freedom
SE= standard error difference

42
Q

What do modified release products need? Why?

A

BE in fasted and fed
WHy- more variation and s/e

43
Q

For modified release, is CI needed?

A

NO but still need to be in 80-125%

44
Q

For multiple dose MR drugs do you need to fast, fed or both?

A

fast unless need food

45
Q

For fed state what is the choice of food?

A

high calorie and high fat= more effect on git physiology

46
Q

If a drug is toxic which is better crossover or parallel?

A

parallel

47
Q

For non linear drugs if it saturates which dose should you use?

A

lowest

48
Q

For non linear drugs if it has great than expected AUC which dose should you use?

A

highest

49
Q

What is a long half life?

A

> 24hrs

50
Q

What is the BE criteria for drugs with long half lives?

A

do for 3 half lives, parallel, in volunteers

51
Q

What is a critical dose drug?

A

small difference in dose lead to bad therapeutic outcomes

52
Q

What are BE requirements for CDDs?

A

90-112%
both fasted and fed

53
Q

Whenis steady state studies for CDD needed?

A

in patients that already need the drug,

54
Q

What parameters are needed for combination products?

A

PK parameters assessed for each active ingredient

55
Q

What value indicates hughly variable drug?

A

> 30% ANOVA-CV

56
Q

What is formula for ANOVA-CV?

A

= sqroot (residual variance) x 100%

57
Q

FOr drugs with measurable endogenous levels what should dose be?

A

high enough to differential exogenous and endogenous

58
Q

What is aqueous solubility a trait of?

A

medicinal ingredient

59
Q

What are the 4 BCS categories?

A

1= High sol, high perm
2- low sol, high perm
3- high sol, low perm
4- low, low

60
Q

What drug can only be BCS biowaivered?

A

IR

61
Q

How do you classify solubility?

A

highest dose of IR

62
Q

WHen is it high permeability?

A

> 85%

63
Q

What is a Caco-2 assay?

A

for permeability

64
Q

What are the key factors for absorption?

A

solubility and permeability

65
Q

For each BCS category what is extent of absorb?

A

1- good
2- dissolution limited
3- permeability limited
4-bad

66
Q

What is max amount of excipient from reference allowed if disrupt absorption to get biowaver?

A

10%

67
Q

What is rate limiting step for category 1?

A

dissolution or gastric empty

68
Q

What is considered rapid dissolution?

A

> 85% in <15 minutes

69
Q

Can you get a biowaiver if the two products are different salts?

A

only if class 1

70
Q

WHat also cant get biowaivers?

A

Class 4, narrow TI, absoprtion in oral cavity

71
Q

How to do a comparative dissolution test?

A

900 ml of medium, temp 37.1 degrees celsius, paddle to stir, 3 buffers

72
Q

What is the f2 variable?

A

similarity factor to compare for biowaiver

73
Q

What f2 value indicates similar?

A

50%

74
Q

When is a f2 test not necessary?

A

if 85% dissolved in under 15 minutes

75
Q
A

Pharm 225 (3 decks)

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